FDA.reportPublic FDA data

NDC 49967-397 - Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49967-397
Package NDCs from labels
49967-397-01, 49967-397-02
Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2025-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsL'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.2025-12-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-397-01Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology1 in 1 CARTONLOTION14
49967-397-01Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology90 mL in 1 TUBELOTION904
49967-397-02Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology1 in 1 CARTONLOTION14
49967-397-02Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology200 mL in 1 TUBELOTION2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-397GARNIER OMBRELLE COMPLETE SENSITIVE ADVANCED LIGHTWEIGHT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE AND DROMETRIZOLE TRISILOXANE) LOTION [L'OREAL USA PRODUCTS INC]34 package rows20240101_f34fcf82-9b85-4ff8-8e80-fa92f9c5a606.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 96 of 218 · 4,358 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.0fb58346-a638-3091-e063-6394a90ad7542025-10-28WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TIBENA EVERYTHING MULTI CUSHION SPF50HOMOSALATE, TITANIUM DIOXIDEKONAD CO LTD421eda8f-62b2-30fb-e063-6394a90a49472025-10-27WarningsExact identifier
unii: V06SV4M95S
Bondi Sands Broad Spectrum SPF 60 Sunny Drops Face SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.289efa6d-427b-8be6-e063-6394a90adae32025-10-27WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENECHOP SAVER FRESH CITRUS SPF 15 LIP BALMGood for the Goose Products, LLC2786cec8-0b8e-9c83-e063-6394a90ab3382025-10-23WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Miranda Castros Healing Cell Salts For Bones, Hair, Nails, and TeethCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAMIRANDA CASTRO'S SHOP, LLC267fb775-a03c-f100-e063-6394a90aa8262025-10-23WarningsExact identifier
unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAMIRANDA CASTRO'S SHOP, LLC266e907b-4cdb-fb4f-e063-6394a90aa4342025-10-23WarningsExact identifier
unii: ETJ7Z6XBU4
Bondi Sands Broad Spectrum SPF 60 Sunny Cream BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.2861453a-12e9-faeb-e063-6394a90a527c2025-10-23WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Good Defense Daily Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEOffspring Beauty Co.2a462e60-6353-f791-e063-6294a90a62e32025-10-23WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENESMASHBOX BEAUTY COSMETICS, INC41c4e135-c6df-82d4-e063-6294a90a0ad32025-10-22WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.a29e5a69-d17e-45ef-8dde-e99c6e4a2b222025-10-22WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Body Glaze Essence SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd2a017658-f5ff-d374-e063-6394a90aa5cc2025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Miffy Sunny Defense SPF StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd24802b17-c0ba-1075-e063-6394a90addd52025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd18632155-5feb-5759-e063-6294a90ab88c2025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Paul Frank Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd26345203-3393-60ba-e063-6394a90a7e922025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Keith Haring Tone Blur Essence SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd1d578196-c785-9914-e063-6394a90a05332025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
luminous aqua sunscreen mistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd29fc0c2b-8d10-8704-e063-6394a90ad5042025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.